Overcoming biosimilar uptake barriers will take collaboration and policy change by hospitals, infusion clinics, and health plans, presenters said at the Academy of Managed Care Pharmacy Nexus 2020 Virtual conference.
Hospitals, infusion centers, and payers all need to take steps to promote biosimilar use in order to overcome current uptake barriers, said presenters from Health First of Florida during the Academy of Managed Care Pharmacy’s Nexus 2020 Virtual conference.
“This is really a team effort, and we should all take a multifaceted approach to provide education, update our policies, and prepare staff to really advocate for biosimilar use,” said Gene Terkoski, PharmD, a presenter and senior managed care pharmacist for Health First Health Plans.
The presenters said that increased biosimilar uptake within the Health First integrated delivery network could generate an annual savings of $1.49 million for health plans, $1.41 million for infusion centers, $54,671 for hospitals, and $200,000 for members.
Hospitals face 5 major barriers to biosimilar uptake, according to presenter Jay Pauly, PharmD, system clinical pharmacy manager at Health First. These include insufficient understanding of the FDA’s evidence requirements for biosimilar approval, lack of knowledge of biosimilar safety and efficacy, not having biosimilar interchangeability status, and concern about drug administration locations.
Pauly said that although originator biologics are very expensive and take a long time to develop, costing about $1 billion and taking about 12 years, biosimilars are actually cheaper and quicker to produce because much of the data for biosimilar benefits were already established for the reference product, meaning that biosimilar developers can skip the discovery phase and shorten clinical trials.
Biosimilars can also receive approval from the FDA for multiple indications even if researchers didn’t test for every single indication approved for the reference product (indication extrapolation), which can also save money on clinical development.
To combat lack of understanding and education surrounding biosimilars, Pauly suggested that hospitals establish provider education and training programs, where studies assessing purity and potency of biosimilars, along with analytical and animal studies, would all be highlighted.
Additionally, education materials should emphasize that administering biosimilars at an outpatient facility saves money because biosimilars may be priced lower than a reference product and outpatient care will always be less costly than inpatient care, presenters said.
Also, hospitals could establish automatic substitution policies for treatment-naïve patients to have them start on a biosimilar rather than the reference product.
Infusion Center Barriers
Infusion centers face many of the same barriers as hospitals but may have to work harder to get everyone on board with biosimilars, as physician leaders, pharmacy and therapeutic committees, and providers across specialties must buy into the biosimilar concept, according to Matt Moser, PharmD, one of the presenters and lead clinical hematology and oncology pharmacy specialist for Health First.
Similar to hospitals, Moser said, infusion centers should create proactive training programs for providers and establish automatic biosimilar substitution policies.
Moser said that education and training for infusion center stakeholders must focus on how biosimilars have done so far, extrapolation of indications, "drift,” and biosimilar efficacy.
The European Union’s decade-long head start on using biosimilars compared with the United States showed that biosimilars can reduce drug costs by establishing a competitive market and are just as efficacious as the reference products.
Moser explained that drift, which is the variation from one drug batch to another as a result of changes in the manufacturing process, should not be concerning for providers as drift also exists for reference products.
Switching patients from reference infliximab to a biosimilar was established to be safe in the NOR-SWITCH study despite federal interchangeability designations not being available for biosimilars currently, Moser said.
Health Plan Barriers
According to Terkoski, health plan barriers center around billing and reimbursement confusion, with many payers worrying about how biosimilars are reimbursed, lack of education, and member cost share burdens.
Major health plan policy changes that Terkoski suggested were removal of prior authorization requirements for biosimilars by payers and implementation of step therapy requirements to make it easier for physicians and pharmacists to provide biosimilars to patients and encourage biosimilar use over a reference product from the start.
Terkoski said that education programs should focus on average sales price (ASP) based reimbursement, which is typically the ASP of the biosimilar plus 6% of the reference product’s ASP. However, prior to the establishment of an ASP, early claims for biosimilars result in significantly higher reimbursements because they are based on the wholesale acquisition cost plus 6%.
Terkoski also emphasized that a major concern is that member co-pays will increase as a result of biosimilars. “In reality, the beauty of the coinsurance is that as the cost of the medication decreases, so does the member’s co-pay,” he said.